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Orthodontic Archwire
EUDAMEDClass IIa (EU MDR)
Ref Super-elastic Niti archwires 12 lower NaturalModel NiTi
Identity
- Trade Name
- Orthodontic Archwire EUDAMED
- Device Name
- Orthodontic Archwires EUDAMED
- Model / Reference
- NiTi EUDAMEDSuper-elastic Niti archwires 12 lower Natural EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974435051057 EUDAMED
- Basic UDI-DI
- 697443505AW07JH EUDAMED
- EMDN Code
- Q010405 ORTHODONTIC WIRES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Orthodontic Archwire by Creative Dental — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697443505AW07JH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Creative Dental
- EUDAMED SRN
- CN-MF-000025975
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (2)
- EUDAMED 8f5e6b4a-baba-4a6c-9e68-0e89036edc59 61 fields · synced Jun 19, 2026
- EUDAMED 3b04300b-ec55-4582-858f-b0d0b4199bbf 61 fields · synced Jun 19, 2026